1. Field of the Invention
This invention relates to gynecological medical devices, and more particularly to a medical tool and method for enabling a woman to collect a cervical cell or other biological material sample for use during a screening test for cancer and infections of the cervix.
2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 37 CFR 1.98
The Papanicalou (PAP) test, commonly known as a PAP smear, is an important routine gynecological test usually done annually in sexually active females to screen for cervical cancer. The tests known in the art typically require an in office visit with a gynecologist where the doctor takes a cellular sample of the cervix for lab analysis. Current medical practice requires a gynecologist to insert a speculum into the patient's vagina to access the cervix for tissue sample collection. Many women find this method an uncomfortable, intrusive exam, and opt to not have the routine screening performed.
While certain groups of women are recognized to be at a higher risk for cervical cancer and exposure to a variety of Human Papilloma Virus subtypes, many monogamous women do not fall into the high risk categories. For these women, the screening guidelines recommend testing every three years after three normal annual PAP smears. Cervical Cancer: Backgrounder, National Cancer Institute, Feb. 22, 1999. For many women, the routine screening test would be regularly performed if it could be done in a non-intrusive, private manner. Screening for Cervical Cancer, in Common Screening Tests, David M. Eddy, MD, PhD, Editor, Chapter 10, pages 255-283 (1991).
Of particular relevance to the instant invention is U.S. Pat. No. 5,121,752 to Canna. Canna '752 discloses a self-obtaining PAP smear apparatus which must be used by a woman standing in an upright position. The apparatus includes a rigid, cylindrical speculum, angled endocervical sampler and an elongated angled spatula. The cylindrical speculum includes an angled front orifice designed to fit about the cervix. After insertion, a mirror is used for visual observation to affirm correct placement of the orifice around the cervix. In actual practice, however, obtaining a clear view by speculum of the cervix is difficult even under direct vision. In addition, the length and rigidity of the speculum prevent the use of digital assistance to confirm proper placement.
Although the aforementioned reference discloses one method and apparatus for self-obtaining PAP smears, it fails to teach or disclose an efficient, easy to use method and apparatus that enables digital location of the cervix for accurate placement of the speculum and reliable sampling of the cervical tissue. The present invention meets these needs. The invention provides an efficient tool for privately performing a non-intrusive PAP smear or tissue sample collection without the need for assistance by a gynecologist or other medical practitioner.